From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Hi Beverly, To find out details on EUAs go to the FDA website central for EUAs at  https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019.    They are pumping out lots of them pretty quickly.  Each type of EUA has different requirements and FDA is flexible depending on the EUA you are looking for.  Timelines are not specific I just asked that question of one of my connections at the FDA today.  They are giving priority to more technically [More]

From : Communities>>Regulatory Open Forum
I have not seen anything, but during the interactive EUA process FDA were very clear that we need to continue with 510[k] preparation and offered supportive and constructive comments of where additional information would be needed. Although the EUA team are very busy, they see it as mutually beneficial, well actually in everybody's interests, to help us to a cleared status as soon as possible and the level of interactive engagement has been great. I am not convinced any general guidance would have [More]

From : Communities>>Regulatory Open Forum
Thank you!!! Good to know that everyone is having a wonderful interactive experience. --------------------------------- Beverly Whitaker Beaufort SC United States ---------------------------------

When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.

What does this have to do with PI oversight?



As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?

We have some suggestions.


Assessing Attention to Detail
Any GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.

This is not sexy stuff. That’s why it’s a good indicator of PI oversight.  A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.

Assessing Commitment to Protocol Compliance
During site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”

The A answer:
“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”

The F answer:
“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)

Just Ask
After reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.

There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out.

Epilogue
After running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”

My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.

I was a child bride.

If you found this article helpful, you might also like:
Anticipating Tensions Between Clinical Care and Study Protocol
Avoiding Protocol Deviations

Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…

Wednesday’s initial public offering for Cambridge-based Ra Pharmaceuticals marked the ninth biotech startup to go public this year, tying the number in 2013 but still less than either of the two years since. Ra (Nasdaq: RARX), which has 40 employees in one of the former Pfizer buildings in Alewife, ended up with the third-largest IPO size for any Massachusetts-based biotech in 2016, with a total of $92 million raised from the sale of 7 million shares for $13 each. That’s more than the $86 million…

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

Do we ever learn from our past mistakes? For many years we believed that technology was an inevitable force for good. It would give us instant access to a near infinite amount of information and allow us to easily and instantly connect with nearly anyone on earth. What could go wrong? The answer is that...

Click here to continue reading...

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Congress is starting to consider ways to address the budget cap problem that hangs over the entire FY 21 appropriations process for non-defense discretionary (NDD) programs. Last year, Congress broke a long-running stalemate by agreeing to budget caps for FY 20 and FY 21. They decided to front-load the increases, making spending decisions (relatively) easier […]

WASHINGTON, D.C. – Co-Chairs of the Childhood Cancer Caucus, Reps. Michael McCaul (R-TX), Jackie Speier (D-CA), Mike Kelly (R-PA), and G. K. Butterfield (D-NC), applaud the passage of the Senate companion to their bill – S. 292, the Childhood Cancer STAR Act.

The STAR Act passed the House today by a unanimous vote.  It addresses the four major concerns facing the pediatric cancer community: Survivorship, Treatment, Access, and Research, and will elevate and prioritize the fight against childhood cancer at the National Institute of Health (NIH).

The members released the following joint statement:

"Today was a long anticipated day for the pediatric cancer community, and one to be celebrated.  This bill is the most comprehensive childhood cancer bill to ever pass Congress and will finally head to the president’s desk to be signed into law. Childhood cancer remains one of the deadliest killers of our kids and we as a Congress, and a nation, must say, ‘Enough is enough.’  As co-chairs of the Childhood Cancer Caucus, we would like to thank all those who made this possible, including the Alliance for Childhood Cancer and the entire childhood cancer advocacy community.”

Click here to watch McCaul’s floor remarks ahead of the House passage of the STAR Act.

Rick Bright confirmed as having left his position as director of BARDA as the agency provides aid to develop solutions for COVID-19.

J&J agrees a manufacturing partnership with Emergent, as it looks to hit its target of one billion doses.

AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders.

The WHO and world leaders commit to a fund to accelerate development of vaccines, tests and treatments for COVID-19.

The likelihood of an effective vaccine being developed and scaled up in less than 12 months is unrealistic, suggests GlobalData analyst.

Pfizer partners with Valneva to progress Phase II-stage vaccine candidate for Lyme disease.

Ajinomoto agrees partnership to manufacture leronlimab, which is currently undergoing clinical trials for the treatment of COVID-19.

Sanofiâs insulin aspart biosimilar receives positive opinion from the EMAâs CHMP.

On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading →

Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) On September 8, we posted a blogspot about our recent article published in Health Law in Canada, in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally.  We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating.  We offered example [...]

Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...]

by Nina Martin and Bernice Yeung

When Alfredo Pabatao told his family that he had helped move a suspected coronavirus patient through the hospital where he’d worked as an orderly for nearly 20 years, he didn’t make a big deal out of it. “My parents are the type of parents who don’t like to make us worry,” his youngest daughter, Sheryl, recalled. But Sheryl was concerned that her father’s vulnerabilities weren’t being given more consideration as he toiled on the pandemic’s front lines in hard-hit northern New Jersey. “Why would they let a 68-year-old man with an underlying heart condition … transport a suspected COVID patient when there’s younger transporters in the hospital who could do it?”

Sheryl’s mother, Susana, was an assistant nurse in a long-term care facility where she often pulled double shifts, saving money for her annual trips back to the Philippines. At 64, she wasn’t much younger than the elderly patients she helped bathe and feed, and she had diabetes, which increased her risk of severe complications if she got sick. The nursing home wasn’t providing adequate personal protection equipment, Susana reported, so Sheryl brought home a stash of surgical masks for her mother to wear on the job. That didn’t go over well with Susana’s managers, Sheryl said: “They gave her a warning, saying she shouldn’t be wearing that. … She was really mad.”

Alfredo fell ill first, his symptoms flaring on March 17. Susana soon developed a fever. The couple had grown up on the same street in Manila and shared a romance that reminded their daughter of a telenovela; after 44 years of marriage and five children, they were all but inseparable. “Where mom goes, my dad goes. Where my dad goes, my mom goes. That’s the way they are,” Sheryl said. The day Alfredo was admitted to the ICU, his heart failing, Susana checked into the same hospital. They died four days apart.

Filipino American medical workers have suffered some of the most staggering losses in the coronavirus pandemic. In the New York-New Jersey region alone, ProPublica learned of at least 30 deaths of Filipino health care workers since the end of March and many more deaths in those peoples’ extended families. The virus has struck hardest where a huge concentration of the community lives and works. They are at “the epicenter of the epicenter,” said Bernadette Ellorin, a community organizer.

Some of the largest Filipino enclaves on the East Coast are in the New York City borough of Queens and northern New Jersey — the very places now being ravaged by COVID-19.

Filipinos are on the front lines there and across the country, four times more likely to be nurses than any other ethnic group in the U.S., experts say. In the New York-New Jersey region, nearly a quarter of adults with Filipino ancestry work in hospitals or other medical fields, a ProPublica analysis of 2017 U.S. census data found. The statistic bears repeating: Of every man and woman in the Filipino community there, one in four works in the health care industry.

“So many people can rattle off five, 10 relations that are working in the medical field,” said filmmaker Marissa Aroy, whose most recent documentary is about Filipino nurses. Her parents were registered nurses in California, and various relatives are in health care professions, including a cousin who works in a rehab center in the Bronx and recently recovered from COVID-19. “Think about all of those family members who are going to be affected,” Aroy said. “We’re talking about huge family structures here.”

The scale of the trauma and the way it is unfolding are “similar to times of war,” said Kevin Nadal, a professor of psychology at John Jay College of Criminal Justice and The Graduate Center of the City University of New York who has written extensively about Filipino American psychology and culture.

The majority of the reported deaths have involved nurses, including Susan Sisgundo and Ernesto “Audie” DeLeon, who worked at Bellevue Hospital in New York City, and Marlino Cagas, who spent 40 years as a pharmacy tech at Harlem Hospital before embarking on a nursing career at the age of 60. A handful, including Jessie Ariel Ferreras, a family practitioner in Bergen County, were doctors. Others worked in support roles, like Louis Torres, 47, the director of food services at a nursing home in Woodside, Queens, and his 73-year-old mother, Lolita, or Lely, a clerk at a nearby hospital. They lived together and fell sick around the same time, both developing pneumonia. Lolita died on April 7, her son, the following day.

Don Ryan Batayola, a 40-year-old occupational therapist, was from a big, tight-knit family and lived in Springfield Township, New Jersey. He is believed to have caught the virus from a patient and was rushed to the hospital on March 31. By April 4, he had improved enough to FaceTime with his wife, also an occupational therapist who was sick and self-isolating at home, their children sheltering with relatives. Then, an hour later, he went into cardiac arrest.

One of the most wrenching aspects of the epidemic is the sense of disconnection and helplessness in a community that stakes its economic well-being on providing care and comfort and cherishes its closeness. So many members of Batayola’s extended family are health care workers, “we could almost open our own hospital,” said his oldest sister Aimee Canton, an oncology nurse in Northern California. But to protect each other, they’ve had to remain apart, with no idea when they’ll be able to come together again. “It’s so sad when you’re a nurse,” Canton said, “and you can’t even help your own family.”

---

Almost all the deaths of Filipino American health care workers that ProPublica found involve people, like the Batayolas, who immigrated during the 1970s to 2000s, when critical shortages created opportunities for medical personnel with the right training.

But the story of Filipino nurses in the U.S. goes back much further, to the end of the Spanish-American War in 1898, when the Philippines became a U.S. territory, said Catherine Ceniza Choy, a professor of ethnic studies at the University of California, Berkeley, and author of “Empire of Care: Nursing and Migration in Filipino American History.” One legacy of the colonial era is a network of hundreds of Americanized nursing schools that eventually produced tens of thousands of caregivers a year, making the country “the leading exporter of nurses in the world,” Choy said.

Nursing offered an escape route from economic and political instability and a path to the middle class for those who had few other options. It also appealed to deeply held cultural values: “kapwa,” Tagalog for “a feeling of interconnectedness to all people, putting others before yourself and taking care of the community,” Nadal said, and “utang ng loob,” the idea that people owe a debt to each other and to those who came before.

Most nurses trained in the Philippines who sought work abroad hoped to end up in the U.S. (They also migrated in large numbers to the Middle East and the U.K.) American immigration policies ebbed and flowed depending on labor shortages and political expediency. In the first third of the 20th century, the numbers of Filipino nurses were small; most workers from the islands were sent to the fields of California and the plantations of Hawaii. Then, in the wake of the Great Depression, Filipino immigrants were capped at just 50 per year, rising to 100 after World War II.

After the war, U.S. nursing shortages grew acute. Even as the passage of Medicare and Medicaid made health care more accessible to the elderly and poor, the rise of the feminist movement, which opened up professional opportunities for American women, made caregiver work less appealing, Choy said. The Immigration Act of 1965 swept aside the long-standing system of country-based quotas, instead giving preference to immigrants with professional degrees. Tens of thousands of Filipino nurses answered the call.

Caregivers on the Front Lines

The scale of losses among Filipino Americans from COVID-19 is only beginning to sink in. Clockwise from top left: Don Ryan Batayola, an occupational therapist; Alfredo Pabatao, a hospital orderly; Susan Sisgundo, a neonatal ICU nurse; Ernesto “Audie” DeLeon, a hospital nurse; Susana Pabatao, a long-term care nurse; Daisy Doronila, a correctional facility nurse.

Many ended up at inner-city and rural hospitals that had the greatest difficulty recruiting staff, often working the least desirable jobs and shifts, including, in the 1980s and ’90s, on the front lines of the AIDS epidemic. It was part of a historical pattern, said Nadal, of “immigrants doing a lot of the dirty work that people don’t want to do... being painted as heroes, when in reality they are only put in these positions because their lives are viewed as disposable.”

Yet it was a template for economic security that many of their American-born children and grandchildren embraced. “It’s like any kind of family dynamic,” Aroy said. “You see your parents do the job. And so then you know that that’s accessible to you. As a second- generation kid, I always knew that was a path for me if I wanted it.”

Today, people of Filipino ancestry comprise about 1% of the U.S. population but more than 7% of the hospital and health care workforce in the United States — nearly 500,000 workers, according to census data. They find themselves fighting not just a potentially lethal illness, but the scapegoating stoked by President Donald Trump and supporters who have taken to calling COVID-19 the “Chinese virus.” Since late March, civil rights organizations have received nearly 1,500 reports of anti-Asian hate incidents, mostly from California and New York, including against Filipino Americans.

“This anti-Asian racism that’s happening right now,” Aroy said, “what it makes me want to do is scream out: ‘How dare you treat us like the carriers? We are your caregivers.’”

---

A host of factors, from medical to cultural, have put large numbers of Filipinos in harm’s way and made them vulnerable to the types of severe complications that often turn deadly. They begin with the specific type of health care work they do.

A survey by the Philippine Nurses Association of America published in 2018 found that a large proportion of respondents were concentrated in bedside and critical care — “the opposite of social distancing,” said executive director Leo-Felix Jurado, who teaches nursing at William Paterson University in Wayne, New Jersey. Many of the organization’s members have contracted the virus, he said, including the current president, New Jersey-based registered nurse Madelyn Yu; she is recovering, but her husband died.

For Daisy Doronila, employed at the Hudson County Correctional Facility in northern New Jersey for more than two decades, the profession was almost a religious calling. “My mom had a very, very humble beginning,” said her only child, Denise Rendor. “She really wanted to take care of people that no one wanted to take care of.”

Doronila saw her responsibilities to her colleagues no less seriously. The single mother and devout Catholic “was always the most reliable person at the job,” Rendor said. “If there was a snowstorm, people called out, nope, not her: ‘I’ll be there.’” As a kid, Rendor sometimes resented the missed volleyball games and dance recitals. Looking back now, “I don’t think I would have the life that I had had my mom not worked so hard.”

It’s not clear how Doronila contracted the virus, though the Hudson County jail has had at least four deaths. Once she fell ill in mid-March, she was turned away for testing by clinics and doctors on three occasions because her symptoms didn’t meet the criteria at the time, Rendor said. On March 21, Doronila started feeling breathless and drove herself to urgent care, which sent her by ambulance to the hospital. She died on April 5 at the age of 60.

If she hadn’t gotten sick, Rendor is sure she would have been volunteering for extra shifts. “That’s just who my mother was. She was just always willing to help.”

That selflessness is common among Filipino immigrants, said Zenei Cortez, a registered nurse in the San Francisco Bay Area who is the president of the California Nurses Association/National Nurses United. “They have such a profound willingness to work that they would forget their own well-being,” she said. “They would think of their loved ones in the Philippines — if they don’t work, then they can’t send money back home.”

In 2019, Filipinos abroad sent $35 billion back to the Philippines, making it the fourth-largest recipient of overseas remittances in the world; many are also helping to support networks of relatives in the U.S. “That’s the economic factor that is on the minds of a lot of Filipino nurses,” Cortez said. “If we miss work, there will be no income.”

It’s a worry that keeps many Filipinos doing sometimes-grueling labor well into their 70s. Doronila’s colleague at the Hudson County jail, nurse Edwin Montanano, was 73 when he died in early April. Jesus Villaluz, a much-beloved patient transporter at Holy Name Medical Center in Teaneck, one of the worst-hit hospitals in northern New Jersey, was 75. “They cannot in their conscience walk away from patients who need them,” said Maria Castaneda, a registered nurse and the secretary-treasurer of 1199SEIU United Healthcare Workers East, who immigrated from the Philippines in 1984. “At the same time, they are there in solidarity with other co-workers. If they are not there, it adds to the burden of those who are working.”

COVID-19 risks are magnified in people who are older or suffer underlying chronic conditions. Filipinos have very high rates of Type II diabetes and cardiovascular disease, both of which render the virus more dangerous. “They’re doing amazing things and helping others to survive,” Nadal said. “But they’re putting themselves at risk because they have immuno-compromised traits that make them susceptible to severe sickness and death.”

And in many situations, they’ve been forced to do that work without proper PPE and other safeguards, said Ellorin, the Queens-based community organizer and executive director of the advocacy group Mission to End Modern-Day Slavery. They are “being infected and not being protected, and then their families, or whoever they live with, are getting infected.”

Sheryl Pabatao thinks of the many people she knows who are working in hospitals and other medical settings and feel unable to speak out. “Even though they don’t want to do things, they still do it because they don’t want to lose their jobs.”

---

When they first applied to immigrate to the U.S. in the 1980s, Alfredo Pabatao was in the car business; Susana was a former nursing student turned housewife and mother of two. By the time their petition was approved about 14 years later, their two eldest children were too old to qualify to come to the U.S. with their parents, so the Pabataos were forced to leave them behind, bringing only their youngest two daughters and son. “To this day, that was one of the hardest things — being separated from everyone,” Sheryl said.

They arrived in the U.S. a few weeks after 9/11. One of Alfredo’s sisters, a registered nurse, helped him get a job transporting patients at her hospital, now known as Hackensack Meridian Health Palisades Medical Center, in North Bergen, New Jersey. “My father grew up with wealth, and when he came here, he had to be modest and humble,” Sheryl said. Susana earned her assistant nursing certification while working as a grocery store cashier, then went to work at what is now called Bergen New Bridge Medical Center in Paramus, the largest hospital and licensed nursing home in the state. Taking care of elderly people helped ease the sadness and guilt at what she had left behind. “She was not able to take care of her own mother,” Sheryl said. “So when she does her job here, she cares for them like her own.”

America proved to be both generous and hard. The couple prospered enough to buy a house, then lost it in the Great Recession. They managed to rebuild their lives and gained their U.S. citizenship, the kids choosing careers in the pharmaceutical side of health care. After 18 years in the same job, Alfredo was waiting for Susana to retire so he could, too.

Then came the pandemic.

Sheryl had been following the news reports from China since early February and was concerned enough about her family to procure a small supply of masks before vendors ran out; “I’d put my parents in a bubble if I can,” she said. Her father was more easygoing: “He has survived so many things in his life. His attitude is: ‘If I get it, I get it. I’ll be OK with it.’”

Sheryl doesn’t know how the responsibility fell to him to transport a patient suspected of having COVID-19 during the second week in March. “But knowing my dad, he agrees to anything. He has that work ethic: ‘This is my job. If I can do it, l do it.’ Knowing him, if one of the other [orderlies] didn’t want to transfer the patient, they asked him and he said yes.”

When Susana found out her husband had been exposed to the virus that way, she was not happy, Sheryl said. Susana was having her own issues at the nursing home. In mid-March, she received an email from her bosses that warned in boldface, “Facemasks are to be used only by staff who have an authorized or clinical reason to use them. Do not wear non-hospital issued facemasks.” It was a policy Susana complained was being made by people who weren’t doing bedside care and didn’t understand the real risks. She was also told the masks would scare patients. She pretended to obey the directive when her managers were around, Sheryl said, “but my mom was stubborn, so when they left, she put [her mask] back on.”

Bergen New Bridge called Susana a “valued” employee who is “greatly missed.” The hospital denied that it has experienced any PPE shortages, but it noted that “guidance from federal and state health officials regarding the use of PPE has been evolving.” Early on, “it was recommended that masks were to be worn only by those individuals who were sick or those who were caring for COVID-19 patients.” Once the virus began spreading within the community, “we quickly moved to universal masking of all employees,” the hospital said. “Like all healthcare facilities, our Medical Center has stressed the importance of using hospital-issued PPE, as guided by the CDC.”

As of April 29, New Bridge’s long-term care facility had recorded 120 confirmed COVID-19 cases and 26 deaths. Hackensack Meridian Health didn’t respond to ProPublica’s requests for comment about Alfredo’s case.

It wasn’t just Alfredo and Susana who fell ill. Sheryl and her brother, both living at home, caught the virus, too. The weekend before Alfredo’s symptoms emerged, he and the rest of the family attended a gathering in honor of a relative who had died in January from cancer. Alfredo spent much of the party talking to his younger brother; later, the brother ended up with COVID-19 and on a ventilator for nearly three weeks. An aunt of Sheryl’s who is a housekeeper in the same hospital system as Alfredo wasn’t at the gathering but fell ill anyway and was out sick for two weeks. Her symptoms weren’t as severe as those of some of the others; she’s already back at work.

The spread of the virus has been unrelenting for Sheryl. When she returned to her own job as a pharmacy tech this past week, a month after her parents died, she learned that someone who worked at her company — who was also Filipino — had died during her absence. “You have no idea about the extent of this,” she said, “until it hits you.”

Sophie Chou contributed reporting.

Correction, May 5, 2020: This story originally misspelled the first name of the president of the California Nurses Association/National Nurses United. She is Zenei Cortez, not Zeine.

---

by Yeganeh Torbati

Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies.

“Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.”

ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead.

Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.”

In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday.

The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March.

On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures.

Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak.

The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million.

Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely.

---

by Charles Ornstein and Lena V. Groeger

Nursing home residents have been among those hardest hit by the new coronavirus. In some states, more than half of the recorded deaths have been long-term care residents. Some of the homes have been cited for putting residents at “immediate jeopardy” of harm or death, our analysis showed.

And many of the affected homes have been previously written up for violating federal standards. That’s true in California, New Jersey and New York.

We’re updating Nursing Home Inspect to include more information about nursing homes across the country, including past problems with infection control practices, and which ones have had cases of COVID-19 among residents or staff.

We introduced this resource in 2012 as a way to search through tens of thousands of nursing home inspection reports to find problems and trends.

You can easily compare the nursing homes in your state based on how many times they have been cited for violating infection control protocols in the past three inspection cycles (roughly three years). We’ve also added data from The Washington Post on homes with COVID-19 cases. Nursing Home Inspect also allows you to sort by the number of health deficiencies cited by regulators; the number of serious deficiencies per home (that is, deficiencies in which patients were put in immediate jeopardy of harm); the amount of fines imposed; and how often the government has suspended payments to the home for new patients, another type of penalty.

Our data is from the U.S. Centers for Medicare and Medicaid Services (CMS), which has its own website called Nursing Home Compare. We’ve taken the information and organized it into an easy-to-use resource for families and residents, as well as researchers and other journalists.

Our site includes:

• State pages: Every state has its own section that allows you to compare all of the homes in a state on a variety of indicators.

• Individual nursing home pages: Every home has a section listing all of the health deficiencies identified within the past three survey cycles (roughly three years). The full text of these deficiency reports, if available, can be accessed via links from this page to CMS. Each home’s page also has ownership status — whether for-profit, government-run or nonprofit — and whether the home has been labeled by the government as a Special Focus Facility, meaning that it has many more problems than other homes. We’ve also labeled Special Focus Facility candidates, which meet the criteria to be a special focus facility but haven’t yet been designated as one. (We only include health deficiencies, not fire and safety violations, in this database.)

• State-by-state maps: The main page of the app shows how states compare in terms of the percentage of homes with at least one serious deficiency, the average fine paid by homes in the state, and the percentage of homes in each state with at least one infection-related deficiency.

• Top 20 Lists: We’ve listed the homes that have paid the most in fines in the nation and those with the highest number of serious deficiencies.

If homes violate federal standards, CMS may impose fines or suspend Medicare/Medicaid payments to the nursing home for new residents until the facility corrects the deficiency.

If problems persist or are not fixed, CMS can end its agreement with the nursing home. Additional details about CMS’ approach to enforcement can be found here.

Nursing Home Inspect continues to allow you to search through nearly 80,000 inspection reports by keywords, such as “choke” or “maggots,” to look for issues you care about. These search results can be sorted by date, city, state or severity of the deficiency.

Nursing homes are inspected on both a regular schedule and when there is a complaint. Inspectors typically work for state agencies paid by Medicare. If they find problems, known as deficiencies, they rank them on a scale of A to L, the most severe. The vast majority are either labeled D or E.

What you won’t find on these pages are self-reported quality measures for each home. Those can be found on Nursing Home Compare. We also don’t list the state sanctions imposed against homes because those are not centrally collected. For information on penalties within a given state, you should consult the state agency that regulates nursing homes. The federal government has a list of contacts available here.

When reading through inspection reports, it is a good idea to keep in mind the caveats we’ve outlined previously.

How We Combined Data Sources

To compile our app, we used different datasets: a listing of all Medicare-certified nursing homes, inspection violations and penalties, and deficiency report narratives.

We merged spreadsheets containing findings from routine inspections and those identified during complaint visits and kept only health violations, not fire safety violations.

We used each home’s unique identification code to match penalties imposed to the dates of their corresponding inspections so we could display that data together for each home. (We also noted some cases in which a penalty date did not have a corresponding inspection in the database.)

You can find the data we used on these sites:

• For a list of nursing homes: https://data.medicare.gov/Nursing-Home-Compare/Provider-Info/4pq5-n9py

• For penalties: https://data.medicare.gov/Nursing-Home-Compare/Penalties/g6vv-u9sr

• For health deficiency information: https://data.medicare.gov/Nursing-Home-Compare/Health-Deficiencies/r5ix-sfxw

• For deficiency report narratives (updated in April 2020): http://downloads.cms.gov/files/Full-Statement-of-Deficiencies-April-2020.zip

---

by Abrahm Lustgarten

The scientists who study how diseases emerge in a changing environment knew this moment was coming. Climate change is making outbreaks of disease more common and more dangerous.

Over the past few decades, the number of emerging infectious diseases that spread to people — especially coronaviruses and other respiratory illnesses believed to have come from bats and birds — has skyrocketed. A new emerging disease surfaces five times a year. One study estimates that more than 3,200 strains of coronaviruses already exist among bats, awaiting an opportunity to jump to people.

The diseases may have always been there, buried deep in wild and remote places out of reach of people. But until now, the planet’s natural defense systems were better at fighting them off.

Today, climate warming is demolishing those defense systems, driving a catastrophic loss in biodiversity that, when coupled with reckless deforestation and aggressive conversion of wildland for economic development, pushes farms and people closer to the wild and opens the gates for the spread of disease.

Aaron Bernstein, the interim director for the C-Change Center for Climate, Health and the Global Environment at Harvard University’s T.H. Chan School of Public Health, said that ignoring how climate and rapid land development were putting disease-carrying animals in a squeeze was akin to playing Russian roulette.

“Nature is trying to tell us something,” Bernstein said.

Scientists have not suggested that climate played any direct role in causing the current COVID-19 outbreak. Though the virus is believed to have originated with the horseshoe bat, part of a genus that’s been roaming the forests of the planet for 40 million years and thrives in the remote jungles of south China, even that remains uncertain.

Scientists have, however, been studying the coronaviruses of southern China for years and warning that swift climate and environmental change there — in both loss of biodiversity and encroachment by civilization — was going to help new viruses jump to people.

There are three ways climate influences emerging diseases. Roughly 60% of new pathogens come from animals — including those pressured by diversity loss — and roughly one-third of those can be directly attributed to changes in human land use, meaning deforestation, the introduction of farming, development or resource extraction in otherwise natural settings. Vector-borne diseases — those carried by insects like mosquitoes and ticks and transferred in the blood of infected people — are also on the rise as warming weather and erratic precipitation vastly expand the geographic regions vulnerable to contagion. Climate is even bringing old viruses back from the dead, thawing zombie contagions like the anthrax released from a frozen reindeer in 2016, which can come down from the arctic and haunt us from the past.

Thus the COVID-19 pandemic, even as it unfolds in the form of an urgent crisis, is offering a larger lesson. It is demonstrating in real time the enormous and undeniable power that nature has over civilization and even over its politics. That alone may make the pandemic prologue for more far-reaching and disruptive changes to come. But it also makes clear that climate policy today is indivisible from efforts to prevent new infectious outbreaks, or, as Bernstein put it, the notion that climate and health and environmental policy might not be related is “a ​dangerous delusion.”

---

The warming of the climate is one of the principal drivers of the greatest — and fastest — loss of species diversity in the history of the planet, as shifting climate patterns force species to change habitats, push them into new regions or threaten their food and water supplies. What’s known as biodiversity is critical because the natural variety of plants and animals lends each species greater resiliency against threat and together offers a delicately balanced safety net for natural systems. As diversity wanes, the balance is upset, and remaining species are both more vulnerable to human influences and, according to a landmark 2010 study in the journal Nature, more likely to pass along powerful pathogens.

The casualties are amplified by civilization’s relentless push into forests and wild areas on the hunt for timber, cropland and other natural resources. Epidemiologists tracking the root of disease in South Asia have learned that even incremental and seemingly manageable injuries to local environments — say, the construction of a livestock farm adjacent to stressed natural forest — can add up to outsized consequences.

Around the world, according to the World Resources Institute, only 15% of the planet’s forests remain intact. The rest have been cut down, degraded or fragmented to the point that they disrupt the natural ecosystems that depend on them. As the forests die, and grasslands and wetlands are also destroyed, biodiversity sharply decreases further. The United Nations warns that the number of species on the planet has already dropped by 20% and that more than a million animal and plant species now face extinction.

Losing species has, in certain cases, translated directly to a rise in infectious disease.

Americans have been experiencing this phenomenon directly in recent years as migratory birds have become less diverse and the threat posed by West Nile encephalitis has spread. It turns out that the birds that host the disease happen to also be the tough ones that prevail amid a thinned population. Those survivors have supported higher infection rates in mosquitoes and more spread to people.

Similarly, a study published last month in the journal Proceedings of the Royal Society B found that as larger mammals suffer declines at the hands of hunters or loggers or shifting climate patterns, smaller species, including bats, rats and other rodents, are thriving, either because they are more resilient to the degraded environment or they are able to live better among people.

It is these small animals, the ones that manage to find food in garbage cans or build nests in the eaves of buildings, that are proving most adaptable to human interference and also happen to spread disease. Rodents alone accounted for more than 60% of all the diseases transmitted from animals to people, the researchers found.

Warmer temperatures and higher rainfall associated with climate change — coupled with the loss of predators — are bound to make the rodent problem worse, with calamitous implications. In 1999, for example, parts of Panama saw three times as much rainfall as usual. The rat population exploded, researchers found. And so did the viruses rats carry, along with the chances those viruses would jump to people. That same year, a fatal lung disease transmitted through the saliva, feces and urine of rats and mice called hantavirus pulmonary syndrome emerged in Panama for the first time, according to a report in the journal Emerging Infectious Diseases.

As much as weather changes can drive changes in species, so does altering the landscape for new farms and new cities. In fact, researchers attribute a full 30% of emerging contagion to what they call “land use change.” Nothing drives land use shifts more than conversion for farmland and feedstock — a result of the push to feed the planet’s 7.8 billion people. As the global population surges to 10 billion over the next 35 years, and the capacity to farm food is stressed further again by the warming climate, the demand for land will only get more intense. Already, more than one-third of the planet’s land surface, and three-quarters of all of its fresh water, go toward the cultivation of crops and raising of livestock. These are the places where infectious diseases spread most often.

Take, for example, the 1999 Nipah outbreak in Malaysia — the true-life subject matter adapted for the film “Contagion.” Rapid clearcutting of the forests there to make way for palm plantations drove fruit bats to the edge of the trees. (Separate research also suggests that climate changes are shifting fruit bats’ food supply.) They found places to roost, as it happens, alongside a hog farm. As the bats gorged themselves on fruit, they dropped pieces of food from the branches, along with their urine, into the pigsties, where at least one pig is believed to have eaten some. When the pig was slaughtered and brought to market, an outbreak is believed to have been spread by the man who handled the meat. More than 100 people died.

The U.S. Centers for Disease Control and Prevention says that fully three-quarters of all new viruses have emerged from animals. Even the 2014 Ebola outbreak in West Africa is believed to have begun when a boy dug into a tree stump that happened to be the roost of bats carrying the virus.

As Christine Johnson, the associate director of the One Health Institute, an interdisciplinary epidemiological program at the University of California, Davis, puts it, global health policymakers have a responsibility to understand how climate, habitat and land use changes lead to disease. Almost every major epidemic we know of over the past couple of decades — SARS, COVID-19, Ebola and Nipah virus — jumped to people from wildlife enduring extreme climate and habitat strain, and still, “we’re naive to them,” she said. “That puts us in a dangerous place.”

---

Once new diseases are let loose in our environment, changing temperatures and precipitation are also changing how those diseases spread — and not for the better. Warming climates increase the range within which a disease can find a home, especially those transmitted by “vectors,” mosquitoes and ticks that carry a pathogen from its primary host to its new victim.

A 2008 study in the journal Nature found nearly one-third of emerging infectious diseases over the past 10 years were vector-borne, and that the jumps matched unusual changes in the climate. Especially in cases where insects like infection-bearing mosquitoes are chasing warmer temperatures, the study said, “climate change may drive the emergence of diseases.”

Ticks and mosquitoes now thrive in places they’d never ventured before. As tropical species move northward, they are bringing dangerous pathogens with them. The Zika virus or Chikungunya, a mosquito-spread virus that manifests in intense joint pain, were once unseen in the United States, but both were transmitted locally, not brought home by travelers, in southern Texas and Florida in recent years.

Soon, they’ll be spreading further northward. According to a 2019 study in the journal PLOS Neglected Tropical Diseases, by 2050, disease-carrying mosquitoes will ultimately reach 500 million more people than they do today, including some 55 million more Americans. In 2013, dengue fever — an affliction affecting nearly 400 million people a year, but normally associated with the poorest regions of Africa — was transmitted locally in New York for the first time.

“The long-term risk from dengue may be much higher than COVID,” said Scott Weaver, the director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in Galveston. “It’s a disease of poor countries, so it doesn’t get the attention it deserves.”

The chain of events that ultimately leads to a pandemic can be long and subtle, steered by shifts in the ecosystem. The 1999 West Nile outbreak in the U.S., for example, came after climate-driven droughts dried up streams and rivers, leaving pools of stagnant water where mosquitoes bred unhindered. It turns out the loss of water also killed off their predators — dragonflies and frogs that depend on large watering holes were gone.

Coronaviruses like COVID-19 aren’t likely to be carried by insects — they don’t leave enough infected virus cells in the blood. But one in five other viruses transmitted from animals to people are vector-borne, said U.C. Davis’ Johnson, meaning it’s only a matter of time before other exotic animal-driven pathogens are driven from the forests of the global tropics to the United States or Canada or Europe because of the warming climate. “Climate is going to shift vulnerability to that,” Johnson said, “and I think some of these regions are not prepared.”

The changing climate won’t just affect how the diseases move about the planet, it will also shape how easily we get sick. According to a 2013 study in the journal PLOS Currents Influenza, warm winters were predictors of the most severe flu seasons in the following year. The brief respite in year one, it turns out, relaxed people’s natural defenses and reduced “herd immunity,” setting conditions for the virus to rage back with a vengeance.

Even harsh swings from hot to cold, or sudden storms — exactly the kinds of climate-induced patterns we’re already seeing — make people more likely to get sick. A study in the journal Environmental Research Letters linked the brutal 2017-18 flu season — which killed 79,000 people — to erratic temperature swings and extreme weather that winter, the same period in which a spate of floods and hurricanes devastated much of the country. If the climate crisis continues on its current trajectory, the authors wrote, respiratory infections like the flu will sharply increase. The chance of a flu epidemic in America’s most populated cities will increase by as much as 50% this century, and flu-related deaths in Europe could also jump by 50%.

“We’re on a very dangerous path right now,” said the University of Texas’ Weaver. Slow action on climate has made dramatic warming and large-scale environmental changes inevitable, he said, “and I think that increases in disease are going to come along with it.”

---

Twelve months before the first COVID-19 case was diagnosed, a group of epidemiologists working with a U.S. Agency for International Development project called PREDICT, or Pandemic Influenza and other Emerging Threats, was deep in the remote leafy jungle of southern China’s Yunnan province hunting for what it believed to be one of the greatest dangers to civilization: a wellspring of emerging viruses.

A decade of study there had identified a pattern of obscure illnesses affecting remote villagers who used bat guano as fertilizer and sometimes for medicine. Scientists traced dozens of unnamed, emerging viruses to caves inhabited by horseshoe bats. Any one of them might have triggered a global pandemic killing a million people. But luck — and mostly luck alone — had so far kept the viruses from leaping out of those remote communities and into the mainstream population.

The luck is likely to run out, as Yunnan is undergoing enormous change. Quaint subsistence farm plots were overtaken by hastily erected apartment towers and high-speed rail lines, as the province endured dizzying development fueled by decades of Chinese economic expansion. Cities’ footprints swelled, pushing back the forests. More people moved into rural places and the wildlife trade, common to such frontier regions, thrived. With every new person and every felled tree, the bats’ habitat shrank, putting the viruses they carried on a collision course with humanity. By late 2018, epidemiologists there were bracing for what they call “spillover,” or the failure to keep a virus locally contained as it jumped from the bats and villages of Yunnan into the wider world.

In late 2018, the Trump administration, as part of a sweeping effort to bring U.S. programs in China to a halt, abruptly shut down the research — and its efforts to intercept the spread of a new novel coronavirus along with it. “We got a cease and desist,” said Dennis Carroll, who founded the PREDICT program and has been instrumental in global work to address the risks from emerging viruses. By late 2019, USAID had cut the program’s global funding.

USAID did not respond to a detailed list of questions from ProPublica.

The loss is immense. The researchers believed they were on the cusp of a breakthrough, racing to sequence the genes of the coronaviruses they’d extracted from the horseshoe bat and to begin work on vaccines. They’d campaigned for years for policymakers to fully consider what they’d learned about how land development and climate changes were driving the spread of disease, and they thought their research could literally provide governments a map to the hot spots most likely to spawn the next pandemic. They also hoped the genetic material they’d collected could lead to a vaccine not just for one lethal variation of COVID, but perhaps — like a missile defense shield for the biosphere — to address a whole family of viruses at once. (In fact, the gene work they were able to complete was used to test the efficacy of remdesivir, an experimental drug that early clinical trial data shows can help COVID-19 patients.)

Carroll said knowledge of the virus genomes had the potential “to totally transform how we think about future biomedical interventions before there’s an emergence.” His goal was to not just react to a pandemic, but to change the very definition of preparedness.

If PREDICT’s efforts in China had the remote potential to fend off the current COVID pandemic, though, it also offered an opportunity to study how climate and land development were driving disease.

But there has been little appetite for that inquiry among policymakers. PREDICT’s staff and advisers have pushed the U.S. government to consider how welding public health policy with environmental and climate science could help stem the spread of contagions. Climate change was featured in presentations that PREDICT staff made to Congress, according to U.C. Davis’ Johnson, who is now also the director of PREDICT, which received a temporary funding extension this spring. And until 2016, leadership of New York-based EcoHealth Alliance, the research group working under PREDICT funding in Yunnan, was invited several times to the White House to advise on global health policy.

Since Donald Trump was elected, the group hasn’t been invited back.

“It’s falling on deaf ears,” said Peter Daszak, EcoHealth Alliance’s president.

A White House spokesperson did not respond to an emailed request for comment.

What Daszak really wants — in addition to restored funding to continue his work — is the public and leaders to understand that it’s human behavior driving the rise in disease, just as it drives the climate crisis. In China’s forests, he looks past the destruction of trees and asks why they are being cut in the first place, and who is paying the cost. Metals for iPhones and palm oil for processed foods are among the products that come straight out of South Asian and African emerging disease hot spots.

“We turn a blind eye to the fact that our behavior is driving this,” he said. “We get cheap goods through Walmart, and then we pay for it forever through the rise in pandemics. It’s upside down.”

---

by Michael Grabell

On Tuesday, March 31, an emergency room doctor at the main hospital in Grand Island, Nebraska, sent an urgent email to the regional health department: “Numerous patients” from the JBS beef packing plant had tested positive for COVID-19. The plant, he feared, was becoming a coronavirus “hot spot.”

The town’s medical clinics were also reporting a rapid increase in cases among JBS workers. The next day, Dr. Rebecca Steinke, a family medicine doctor at one of the clinics, wrote to the department’s director: “Our message is really that JBS should shut down for 2 weeks and have a solid screening plan before re-opening.”

Teresa Anderson, the regional health director, immediately drafted a letter to the governor.

But during a conference call that Sunday, Gov. Pete Ricketts made it clear that the plant, which produces nearly 1 billion pounds of beef a year and is the town’s largest employer, would not be shut down.

Since then, Nebraska has become one of the fastest-growing hot spots for the novel coronavirus in the United States, and Grand Island has led the way. Cases in the city of 50,000 people have skyrocketed from a few dozen when local health officials first reported their concerns to more than 1,200 this week as the virus spread to workers, their families and the community.

The dismissed warnings in Grand Island, documented in emails that ProPublica obtained under the state’s public records law, show how quickly the virus can spread when politicians overrule local health officials. But on a broader scale, the events unfolding in Nebraska provide an alarming case study of what may come now that President Donald Trump has used the Defense Production Act to try to ensure meat processing plants remain open, severely weakening public health officials’ leverage to stop the spread of the virus in their communities.

Ricketts spokesman Taylor Gage said the governor explained on the call with local officials that the plant would stay open because it was declared an essential industry by the federal government. Two and a half weeks later, as cases were rising among the state’s meatpacking workers, Ricketts, a Republican businessman whose father founded the brokerage TD Ameritrade, held a news conference and said he couldn’t foresee a scenario where he would tell the meatpacking plants to close because of their importance to the nation’s food supply.

“Can you imagine what would happen if people could not go to the store and get food?” he asked. “Think about how mad people were when they couldn’t get paper products.”

“Trust me,” he added, “this would cause civil unrest.”

In the last two weeks, small meatpacking towns across Nebraska have experienced outbreaks, including at a Tyson Foods beef plant in Dakota City, a Costco chicken plant in Fremont and a Smithfield Foods pork plant in Crete. With the governor vowing to keep plants open, the companies have only in recent days decided to close for deep cleanings as cases have grown to staggering levels.

In Grand Island, two hours west of Omaha, the consequences of the governor’s decision came quickly. The CHI Health St. Francis hospital, which has 16 intensive care beds, was soon overwhelmed. At one point in April, it had so many critical patients that it had to call in three different helicopter companies to airlift patients to larger hospitals in Lincoln and Omaha, said Beth Bartlett, the hospital’s vice president for patient care.

JBS workers felt the strain, too. Under pressure to keep the food supply chain flowing, some of the plant’s 3,500 workers, many hailing from Latin America, Somalia and Sudan, said they were told to report for work regardless. In a letter to the governor last week, Nebraska Appleseed, a nonprofit advocacy group, said a JBS worker had been told by his supervisor that if he tested positive, he should come to work anyway and “keep it on the DL” or he’d be fired. Some workers who’d been told to quarantine after being exposed told ProPublica this week that they were called back to work before the 14-day window recommended by the Centers for Disease Control and Prevention — even if they felt sick. One worker in the offal, or entrails, section recently fainted in the plant, they said, but was told he couldn’t go home.

Cameron Bruett, head of corporate affairs for JBS, said the company has worked in partnership with local officials to prevent the spread of the coronavirus and did not influence the governor’s decision to keep the plant open. He pointed to comments made recently by University of Nebraska Medical Center officials who toured the plant, who said JBS has put in place some “best practices,” including installing barriers on the meat cutting line, communicating new precautions in multiple languages and ensuring the proper use of masks.

Bruett said no one is forced to come to work or punished for calling in sick. “Such actions, if true, would be grotesque and a clear violation of our culture,” he said.

The emails obtained by ProPublica show that local health officials have traced 260 cases to the JBS plant. But that was nearly two weeks ago and almost certainly underestimates the total. Anderson, who directs the Central District Health Department, said she hasn’t had enough tests to do targeted testing of JBS employees and is only testing people when they’re symptomatic. In Grand Island and its surrounding county, 32 people have died from the virus. According to workers, at least one of those was a JBS employee.

Across the country, more than 10,000 COVID-19 cases have been linked to meatpacking plants, and at least three dozen workers are known to have died, a ProPublica review of news reports and government health data shows.

While cases in the worst hit urban areas like New York appear to have plateaued, the nation’s meatpacking towns have continued to see spikes. A few large outbreaks have dominated public attention, but COVID-19 cases have popped up in well over 100 plants in mostly rural communities. There the virus’s impact is magnified by the workers’ sometimes cramped living conditions, with multiple generations of immigrant and refugee families often residing together in apartments, houses and trailers.

Before Trump’s order, more than 30 plants had shut down at least briefly to increase cleaning and control the spread among their workforces. The various closures have cut beef and pork production by more than a third compared with last year, causing supply chain disruptions for some supermarkets and fast-food chains.

Some of those closures show the role public health officials have had in the actions of large meatpacking companies like JBS, which has beef, pork and poultry plants in 27 states.

In Colorado, Dr. Mark Wallace of the Weld County Department of Public Health and Environment and state health director Jill Hunsaker Ryan grew worried that that if the coronavirus spread at JBS’ Greeley plant, it would have a “devastating” effect on the community that “would quickly overwhelm the medical resources available in the hospitals.”

Unlike Nebraska, Colorado’s health officials eventually ordered the JBS plant to close. But documents obtained by ProPublica show the protracted debate that came before that decision, with JBS invoking the governor to question the formal closure order. By the time the order was issued, some public officials felt the virus had been given too big a head start.

Like Grand Island, Greeley officials were already hearing by the end of March that hospital emergency rooms were seeing a “high number of JBS employees,” according to an email Wallace sent April 1 to the plant’s occupational health director.

“Their concern, and mine, is far too many employees must be working when sick and spreading infection to others,” Wallace wrote, urging the plant to take additional safety measures.

Three days later, Wallace wrote a more detailed letter to JBS’ human resources director, Chris Gaddis, documenting the virus’s spread and threatening to shut the plant down if it didn’t screen employees and ensure they could work 6 feet apart.

But as days passed, the situation in Greeley didn’t improve.

“Want you to know my colleagues are not reassured by what I’m sharing about measures being implemented,” Wallace wrote to Gaddis. “‘The cat’s out of the bag’ is what all health care providers are saying — too many sick people already, too much spread already, etc.”

After nine days of back-and-forth, JBS agreed to close the plant and Hunsaker Ryan and Wallace issued a formal shutdown order. But negotiations seemed to stretch until the last minute, emails show.

After Hunsaker Ryan sent JBS the order on the afternoon of April 10, Gaddis appeared confused. “It is our understanding from the telephone conversation that the governor did not want this letter sent,” Gaddis wrote. “Please confirm it was properly sent.”

Bruett said the company’s impression was that the governor didn’t feel a formal order “was necessary given our voluntary decision to shut down.” But Conor Cahill, a spokesman for Gov. Jared Polis, said: “Of course the governor wanted the health order sent. The governor has been clear that JBS needs to be more transparent with their staff and the public about the situation at their plant.”

Notified of the shutdown by his staff, Greeley Mayor John Gates wrote in an email, “In my opinion, that should have happened a week ago for the health and safety of their employees.”

On Wednesday, the state announced the latest numbers on the JBS outbreak: 280 employees had tested positive for COVID-19, and seven of them had died.

The Grand Island beef plant opened in 1965 in a sugar beet farming area. In recent decades, the plant has drawn immigrants from Mexico and Central America, and more recently refugees from Somalia and Sudan. In a sign of the area’s shifting workforce, Somali residents have opened a mosque in the old El Diamante nightclub and a community center in the former Lucky 7 Saloon next to a Salvadoran restaurant named El Tazumal.

Members of those communities became among the first to hit the area’s medical clinics as the virus began to spread. By the last week in March, the Family Practice of Grand Island, where Steinke works, had opened a special respiratory clinic to handle COVID-19 patients. That week, six of the patients had come from JBS. But over three days from March 30 to April 1, the clinic saw 25 patients that carried JBS insurance, indicating they were either employees or their dependents.

Danny Lemos’ father was one of the first JBS workers to get sick from the virus in late March. The 62-year-old, who’d worked at the plant for a year, had developed a fever and a cough.

“One day, he was laying in the living room on a chair, wrapped up in a blanket, shivering,” Lemos said. “My mom takes his temperature, and he had a temperature of 105 and he was really having trouble breathing.”

His father was rushed to the hospital and put on a ventilator.

Within days, Lemos said he also started having trouble breathing and joined his father in the ICU. Lemos, 39, was put in a medically induced coma and given a 20% chance of living, he said.

Surprisingly, he said, he eventually recovered and was released from the hospital in late April. His father, Danny Lemos Sr., has been in the hospital for more than a month, most of the time on a ventilator, and is only now starting to recover.

Lemos said JBS should have taken better precautions.

“Shutting down right away, I think, probably would have helped a ton,” he said. “Do I think it would have kept everybody from getting sick? No, because those same people are still going to be out and about in the community. But just being so many people in one building, it was like a ticking time bomb.”

In an interview this week, Steinke said that it was hard to get the message across to JBS that more needed to be done.

“Even if they did not stop or shut down, if they would have put in better protections right from the start,” she said, “we would not have seen such a rapid rise in cases.”

At one point before the governor’s decision, the emails ProPublica obtained show, officials found language on the U.S. Department of Agriculture’s website that said local authorities could close a plant and the USDA would follow those decisions, potentially giving the health district some leverage.

“I guess I will send it to … HR there and maybe he will take us more seriously,” Anderson, the local health director, wrote in an email to the city administrator.

Under Trump’s executive order, that guidance has been reversed: The USDA could try to overrule local decisions if federal officials disagree.

That could pose a risk to the USDA’s own workforce of federal food inspectors, who work inside the plants to ensure the meat is safe to eat. According to the emails, some inspectors at the JBS plant also tested positive. Because inspectors sometimes monitor multiple sites, one inspector noted that she had recently worked in two other plants that have also had outbreaks, potentially spreading the virus within other plants.

“From my perspective,” temporarily closing the JBS plant “would have reduced the transmission,” Anderson said in an interview this week. “But if you shut down a plant and your 3,700 employees have nowhere to go, where are they going to go and how far is the spread going to be outside the plant vs. inside the plant? And if you end up going a month, what happens to their ability to feed their families?”

Anderson said that the “general feeling” she got from the call with the governor was that they needed to do more testing. So after the governor blocked the effort to close the plant, she continued to try to work collaboratively with JBS to encourage more testing of their employees.

In the emails, JBS officials said they were open to testing but repeatedly expressed concern about public disclosure of the results. “We want to make sure that testing is conducted in a way that does not foment fear or panic among our employees or the community,” JBS chief ethics and compliance officer Nicholas White wrote in an email to Anderson on April 15.

A week later, after the number of JBS cases was released by Anderson, Tim Schellpeper, president of the company’s U.S. beef processing operations, emailed her that he was worried about the amount of national attention it was attracting. “Have you given more thought to adding clarity/correction around this in your comments today?” he asked.

As JBS officials fretted about the optics of testing their employees, tensions within the families of the workers mounted. As the number of sick workers grew, the daughter of one worker, Miriam, said she was panicking about what would happen to her mother, who worked on the plant’s kill floor. At the end of every shift, she said, she called her mother to make sure she was okay.

“It was dreadful,” said Miriam, who asked that her last name not be used to protect her mother from retaliation. “It was just kind of living in fear waiting for the day she would have a fever. We knew it was going to happen because she’s a JBS employee. We didn’t think it was preventable anymore.”

Then, one day, she got a call from her mother, telling her that she had developed a fever and was being sent home.

“As she was changing in the locker room, she calls me and you can just hear the fear in her voice,” Miriam said.

Shortly after, her father tested positive for the virus too. Thankfully, she said, both her parents had only mild symptoms and have since recovered. But JBS and the governor should have done more, Miriam said.

“It just seemed like they were kind of careless,” she said. “I think it would have been a smart idea if not to close down the plant, to take more action to help the employees. They’re essential, but they need protection. They need to be kept safe.”

In the meantime, Ricketts has said that his approach of keeping the state “open for business” worked. And at a news conference Friday, he underscored the importance of the meatpacking industry to the state’s economy, proclaiming May as “Beef Month” in Nebraska.

---

by Joshua Kaplan and Benjamin Hardy

On April 17 in Toledo, Ohio, a 19-year-old black man was arrested for violating the state stay-at-home order. In court filings, police say he took a bus from Detroit to Toledo “without a valid reason.” Six young black men were arrested in Toledo last Saturday while hanging out on a front lawn; police allege they were “seen standing within 6 feet of each other.” In Cincinnati, a black man was charged with violating stay-at-home orders after he was shot in the ankle on April 7; according to a police affidavit, he was talking to a friend in the street when he was shot and was “clearly not engaged in essential activities.”

Ohio’s health director, Dr. Amy Acton, issued the state’s stay-at-home order on March 22, prohibiting people from leaving their home except for essential activities and requiring them to maintain social distancing “at all times.” A violation of the order is a misdemeanor, punishable by up to 90 days in jail and a $750 fine. Since the order, hundreds of people have been charged with violations across Ohio.

The state has also seen some of the most prominent protests against state stay-at-home orders, as large crowds gather on the statehouse steps to flout the directives. But the protesters, most of them white, have not faced arrest. Rather, in three large Ohio jurisdictions ProPublica examined, charges of violating the order appear to have fallen disproportionately on black people.

ProPublica analyzed court records for the city of Toledo and for the counties that include Columbus and Cincinnati, three of the most populous jurisdictions in Ohio. In all of them, ProPublica found, black people were at least four times as likely to be charged with violating the stay-at-home order as white people.

As states across the country attempt to curb the spread of COVID-19, stay-at-home orders have proven instrumental in the fight against the novel coronavirus; experts credit aggressive restrictions with flattening the curve in the nation’s hotbeds. Many states’ orders carry criminal penalties for violations of the stay-at-home mandates. But as the weather warms up and people spend more time outside, defense lawyers and criminal justice reform advocates fear that black communities long subjected to overly aggressive policing will face similarly aggressive enforcement of stay-at-home mandates.

In Ohio, ProPublica found, the disparities are already pronounced.

As of Thursday night in Hamilton County, which is 27% black and home to Cincinnati, there were 107 charges for violating the order; 61% of defendants are black. The majority of arrests came from towns surrounding Cincinnati, which is 43% black. Of the 29 people charged by the city’s Police Department, 79% were black, according to data provided to ProPublica by the Hamilton County Public Defender.

In Toledo, where black people make up 27% of the population, 18 of the 23 people charged thus far were black.

Lt. Kellie Lenhardt, a spokeswoman for the Toledo Police Department, said that in enforcing the stay-at-home order, the department’s goal is not to arrest people and that officers are primarily responding to calls from people complaining about violations of the order. She told ProPublica that if the police arrested someone, the officers believed they had probable cause, and that while biased policing would be “wrong,” it would also be wrong to arrest more white people simply “to balance the numbers.”

In Franklin County, which is 23.5% black, 129 people were arrested between the beginning of the stay-at-home order and May 4; 57% of the people arrested were black.

In Cleveland, which is 50% black and is the state’s second-largest city, the Municipal Court’s public records do not include race data. The court and the Cleveland Police Department were unable to readily provide demographic information about arrests to ProPublica, though on Friday, the police said they have issued eight charges so far.

In the three jurisdictions, about half of those charged with violating the order were also charged with other offenses, such as drug possession and disorderly conduct. The rest were charged only with violating the order; among that group, the percentage of defendants who were black was even higher.

Franklin Country is home to Columbus, where enforcement of the stay-at-home order has made national headlines for a very different reason. Columbus is the state capital and Ohio’s largest city with a population of almost 900,000. In recent weeks, groups of mostly white protesters have campaigned against the stay-at-home order on the Statehouse steps and outside the health director’s home. Some protesters have come armed, and images have circulated of crowds of demonstrators huddled close, chanting, many without masks.

No protesters have been arrested for violating the stay-at-home order, a spokesperson for the Columbus mayor’s office told ProPublica. Thomas Hach, an organizer of a group called Free Ohio Now, said in an email that he was not aware of any arrests associated with protests in the entire state. The Columbus Division of Police did not respond to ProPublica’s request for comment.

Ohio legislators are contemplating reducing the criminal penalties for violating the order. On Wednesday, the state House passed legislation that would eliminate the possibility of jail time for stay-at-home violators. A first offense would result in a warning, and further violations would result in a small fine. The bill is pending in the state Senate.

Penalties for violating stay-at-home orders vary across the country. In many states, including California, Florida, Michigan and Washington, violations can land someone behind bars. In New York state, violations can only result in fines. In Baltimore, police told local media they had only charged two people with violations; police have reportedly relied on a recording played over the loudspeakers of squad cars: “Even if you aren’t showing symptoms, you could still have coronavirus and accidentally spread it to a relative or neighbor. Being home is being safe. We are all in this together.”

Enforcement has often resulted in controversy. In New York City, a viral video showed police pull out a Taser and punch a black man after they approached a group of people who weren’t wearing masks. Police say the man who was punched took a “fighting stance” when ordered to disperse. In Orlando, police arrested a homeless man walking a bicycle because he was not obeying curfew. In Hawaii, charges against a man accused of stealing a car battery, normally a misdemeanor punishable by up to 30 days in jail, were enhanced to a felony, which can result in 10 years in prison, because police and prosecutors said he was in violation of the state order.

The orders are generally broad, and decisions about which violations to treat as acceptable and which ones to penalize have largely been left to local police departments’ discretion.

Kristen Clarke, president of the Lawyers’ Committee for Civil Rights Under Law, a legal organization focused on racial justice, said such discretion has opened the door to police abuse, and she said the U.S. Department of Justice or state governments should issue detailed guidelines about when to make arrests. That discretion “is what’s given rise to these rogue practices,” she told ProPublica, “that are putting black communities and communities of color with a target on their backs.”

In jails and prisons around the country, inmates have fallen ill or died from COVID-19 as the virus spreads rapidly through the facilities. Many local governments have released some inmates from jail and ordered police to reduce arrests for minor crimes. But in Hamilton County, some people charged with failing to maintain social distancing have been kept in jail for at least one night, even without any other charges. Recently, two sheriff’s deputies who work in the jail tested positive for COVID-19. “The cops put their hands on them, they cram them in the car, they take them to the [jail], which has 800 to 1400 people, depending on the night,” said Sean Vicente, director of the Hamilton County Public Defender’s misdemeanor division. “It’s often so crowded everyone’s just sitting on the floor.”

Clarke said the enforcement push is sometimes undercutting the public health effort: “Protecting people’s health is in direct conflict with putting people in overcrowded jails and prisons that have been hotbeds for the virus.”

Court records show that the Cincinnati Police Department has adopted some surprising applications of the law.

Six people were charged with violations of the order after they were shot. Only one was charged with another crime as well, but police affidavits state that when they were shot, they were or likely were in violation of the order. One man was shot in the ankle while talking to a friend, according to court filings, and “was clearly not engaged in essential activities.” Another was arrested with the same explanation; police wrote that he had gone to the hospital with a gunshot wound. The Cincinnati Police Department did not respond to ProPublica’s requests for comment.

In Springfield Township, a small, mostly white Cincinnati suburb, nine people have been arrested for violating the order thus far. All of them are black.

Springfield Township Police Chief Robert Browder told ProPublica in an email that the department is “an internationally accredited law enforcement organization” and has “strict policies ... to ensure that our zero tolerance policy prohibiting bias-based profiling is adhered to.”

Browder said race had not played a role in his department’s enforcement of the order and that he was “appalled if that is the insinuation.”

Several of the black people arrested in Springfield Township were working for a company that sells books and magazine subscriptions door to door. One of the workers, Carl Brown, 50, said he and five colleagues were working in Springfield Township when two members of the team were arrested while going door to door. Police called the other sales people, and when they arrived at the scene, they too were arrested. Five of them, including Brown, were charged only with violating the stay-at-home order; the sixth sales person had an arrest warrant in another state, according to Browder, and police also charged her for giving them false identification.

Brown said one of the officers had left the group with a warning: They should never come back, and if they do, it’s “going to be worse.”

Browder denied that the officers made such a threat, and he said the police had received calls from residents about the sales people and their tactics and that the sales people had failed to register with the Police Department, as required for door-to-door solicitation.

Other violations in Hamilton County have been more egregious, but even in some of those cases, the law enforcement response has stirred controversy. On April 4, a man who had streamed a party on Facebook Live, saying, “We don’t give a fuck about this coronavirus,” was arrested in Cincinnati’s Over-the-Rhine neighborhood, the setting of a 2001 riot after police fatally shot an unarmed black man.

The man who streamed the party, Rashaan Davis, was charged with violating the stay-at-home order and inciting violence, and his bond was set at $350,000.

After Judge Alan Triggs said he would release Davis from jail pretrial because the offense charged was nonviolent, local media reported, prosecutors dropped the misdemeanor and said they would focus on the charge of inciting violence, a felony.

The Hamilton County prosecutor’s office declined to comment on Davis’ case.

In Toledo, there’s been public controversy around perceived differences in the application of the law. On April 21, debate at the Toledo City Council meeting centered around a food truck. Local politicians discussed recent arrests of young black people at house parties, some contrasting them with a large, white crowd standing close together in line outside a BBQ stand, undisturbed by police. Councilmember Gary Johnson told ProPublica he’s asked the police chief to investigate why no one was arrested at a party he’d heard about, where white people were congregating on docks. “I don’t know the circumstances of the arrests,” he said. But “if you feel you need to go into poor neighborhoods and African American neighborhoods, you better be going into white neighborhoods too. … You have to say we’re going to be heavy-handed with the stay-at-home order or we’re going to be light with it. It has to be one or the other.”

Toledo police enforcement has not been confined to partygoers. Armani Thomas, 20, is one of the six young men arrested for not social distancing on a lawn. He told ProPublica he was sitting there with nine friends “doing nothing” when the police pulled up. Two kids ran off, and the police made the rest stay, eventually arresting “all the dudes” and letting the girls go. He was taken to the county jail, where several inmates have tested positive, for booking and released after several hours. The men’s cases are pending.

“When police see black people gathered in public, I think there’s this looming belief that they must be doing something illegal,” RaShya Ghee, a criminal defense attorney and lecturer at the University of Toledo, told ProPublica. “They’re hanging out in a yard — something illegal must have happened. Or, something illegal is about to happen.”

Lenhardt, the police lieutenant, said the six men were arrested after police received 911 calls reporting “a group gathering and flashing guns.” None of the six men were arrested on gun charges. As for the 19-year-old charged for taking the bus without reason, she said police asked him on consecutive days to not loiter at a bus station.

With more than 70,000 Americans dead from the coronavirus, government officials have not figured out how to balance the threat of COVID-19 with the harms of over policing, Clarke said. “On the one hand, we want to beat back the pandemic. That’s critical. That’s the end goal,” she told ProPublica. “On the other hand, we’re seeing social distancing being used as a pretext to arrest the very communities that have been hit hardest by the virus.”

---

UPDATE: The guidance mentioned below was released. Here's the link.

The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:

• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers 

Also notable is that no other advertising or promotional guidances are listed. The draft guidance on presenting risk information turned 10 years old last year. It seemed ripe for an update and perhaps even finalization. That seemed even more likely in the context of OPDP's study of the so-called one-click rule. That study was first announced in 2017. There's no update on the FDA website about the study, but I expected it to be completed last year.

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association.

To read the whole article click on the headline

The development of myocardial injury in COVID-19 patients is associated with an increased risk of death, researchers have found.

To read the whole article click on the headline

Neurological symptoms are common in patients with COVID-19, particularly if they have a severe infection, research published in JAMA Neurology suggests.

To read the whole article click on the headline

Exclusive: Pharmacy staff in care homes are being redeployed to cover other roles during the COVID-19 pandemic, even though demands on care homes are increasing rapidly, The Pharmaceutical Journal has learnt.

To read the whole article click on the headline

Adults with non-valvular atrial fibrillation prescribed apixaban have a lower rate of ischaemic stroke and systemic blood clots compared with those prescribed rivaroxaban, according to a retrospective cohort study in Annals of Internal Medicine.

To read the whole article click on the headline

Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced.

To read the whole article click on the headline

The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.

To read the whole article click on the headline

March 12, 2020 —[Note: Due to the coronavirus epidemic, the Conference has been rescheduled from May.] Healthcare was already the top issue for voters—and the coronavirus pandemic only intensifies the focus heading into a hotly-contested election. Both parties want to “do something” about the cost of healthcare and especially drug prices, and what happens when […]

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]

March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]